Study of Postoperative Chest Tube Management

Yale University

Status and phase: Completed; Phase 4

Conditions: Lung Resection

Treatments: Other: Unreg Pressure; Other: Reg Pressure; Other: Active Suction (Trad); Other: Passive Drainage (Dig); Other: Passive Drainage (Trad); Other: Active Suction (Dig)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02282462

1411014891

Details and patient eligibility

About

A 2 x 2 randomized study testing active versus passive drainage and regulated versus unregulated pleural pressure in patients undergoing anatomic lung resection

Full description

This study is a prospective, multi-center randomized clinical trial at 6 sites. Pre-operative evaluation and the decision for surgical intervention will proceed as currently performed at each center. That is, neither inclusion in nor exclusion from this study will affect the plan of care for patients other than the approach to chest tube management, which is determined by randomization among 4 methods that are in common clinical use. Each enrolled patient will be randomized to either regulated pleural pressure using the Thopaz+ digital chest drainage device or unregulated pleural pressure using a traditional system (multi-chambered system e.g. Pleur-Evac, Atrium-Maquet or similar device as is routine at each institution) and also randomized to either active suction (-20 cm H2O) or passive drainage.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able and willing to read, understand, and provide written consent
• Age 18-90
• Undergoing a segmentectomy, lobectomy, or bilobectomy (including sleeve resection). Both open and minimally invasive (thoracoscopic or robotic) resections are acceptable

Exclusion criteria

• Patients unstable enough to require ICU care for hemodynamic or respiratory problems during the first 7 days postoperatively. Patients admitted to the ICU for other reasons (e.g. bed availability, institutional norm, routine monitoring etc.) should NOT be excluded
• Patients undergoing non-anatomic lung resection only (i.e. wedge resection)
• Patients undergoing anatomic lung resection for bullous disease, lung abscess or bronchiectasis.
• Patients undergoing pneumonectomy or completion pneumonectomy

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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600 participants in 4 patient groups

Reg pressure, Active suction (Dig)

Experimental group

Description:

Regulated pleural pressure with active suction

Treatment:

Other: Active Suction (Dig)

Other: Reg Pressure

Reg pressure, Passive drainage (Dig)

Experimental group

Description:

Regulated pleural pressure with passive drainage

Treatment:

Other: Passive Drainage (Dig)

Other: Reg Pressure

Unreg pressure, Active suction (Trad)

Experimental group

Description:

Unregulated pleural pressure with active suction

Treatment:

Other: Unreg Pressure

Other: Active Suction (Trad)

Unreg pressure, Passive drainage (Trad)

Experimental group

Description:

Unregulated pleural pressure with passive drainage

Treatment:

Other: Unreg Pressure

Other: Passive Drainage (Trad)